Status:
COMPLETED
Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients
Lead Sponsor:
Thammasat University
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
Brief Summary
1. To compare the effectiveness of Benjakul extract capsules at 300 mg per day with Loratadine drug in the treatment of allergic rhinitis patients in small group (Clinical Trial Phase II). 2. To study...
Detailed Description
1. Group 1consists of 30 patients, taking Benjakul dosage 100 mg or 1 capsule 3 times daily. beforeBreakfast, lunch and dinner. 2. Group 2 consists of 30 patients, taking Loratadine dosage 100 mg 1tim...
Eligibility Criteria
Inclusion
- Male and female patients aged between 20-70 years
- Patients have history of allergic rhinitis on the basis of Allergic Rhinitis and its Impact on Asthma : ARIA (itching and nasal obstruction, watery nasal discharge, sneezing ,congestion)
- Patients have moderate allergic rhinitis diagnosed by doctor with a minimum TNSS score of 5 points
- No history of disease : heart disease, kidney disease, liver disease, epilepsy,high blood pressure and severe asthma.
- Normal results in blood test, liver and kidney.
- Not pregnant or breastfeeding.
- Body Mass Index (BMI) 18-35 kg / m2 and normal vital signs.
- Volunteers are willing participants.
Exclusion
- Volunteers who have taken anti-coagulant and anti-platelet aggregation drugs.
- Patients receiving Intranasal steroids.
- Volunteers who get serious side effect from loratadine : fatigue, headache, dry mouth, drowsiness, nausea, stomach ulcers, rash.
- Volunteers who have side effects from Benjakul drug.
- Volunteers who have a temperature.
- Volunteers participating in other research.
- Volunteers who have severe urticaria and anaphalaxis.
- Volunteers who are immunocompromised or have with severe chronic diseases, such as AIDS.
- Volunteers who have taken Macrolides : erythromycin, clarithromycin, Imidazole (ketoconazole, itraconazole, fluconazole) HIV protease Inhibitors, Other drugs that inhibit the enzyme CYP450: cimetidine,metronidazole,zafirlukast, SSRIS
- Volunteers are using drug which extract QT interval, such as Calcium Channel Blockers (eg bepridil, verapamil), Tricyclic Antidepressant, Cisapride, Quinidine and so on.
- Volunteers have nasal septum perforation or have had sinus surgery
Key Trial Info
Start Date :
July 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03376594
Start Date
July 30 2017
End Date
March 31 2018
Last Update
April 26 2018
Active Locations (1)
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1
Faculty of Medicine
Khlong Luang, Changwat Pathum Thani, Thailand, 12120